Brand name: Viread
Drug class: HIV Nucleoside and Nucleotide Reverse Transcriptase Inhibitors

Medically reviewed by Drugs.com on Mar 10, 2024. Written by ASHP.

Introduction

Antiretroviral; HIV nucleotide reverse transcriptase inhibitor (NRTI); also has antiviral activity against HBV.^{1 2 3 200}

Uses for Tenofovir Disoproxil Fumarate

Treatment of HIV Infection

Treatment of HIV-1 infection in adults, adolescents, and pediatric patients ≥2 years of age weighing ≥10 kg; used in conjunction with other antiretrovirals.¹

Commercially available as a single entity and in various fixed-combination preparations that contain 2 or 3 additional antiretrovirals; refer to separate combination product monographs for information related to the specific uses of these products.^{1 230 231 232 233 235 239 240}

Tenofovir disoproxil fumarate (tenofovir DF) is commonly used as part of a dual-NRTI “backbone” of a fully suppressive antiretroviral regimen; consult guidelines for the most current information on recommended regimens.^{200 201 202} Selection of an initial antiretroviral regimen should be individualized based on factors such as virologic efficacy, toxicity, pill burden, dosing frequency, drug-drug interaction potential, resistance test results, comorbid conditions, access, and cost.^{200 201 202}

Preexposure Prophylaxis for Prevention of HIV-1 Infection

Used in combination with emtricitabine for preexposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk HIV-negative adults and adolescents; refer to the combination product monograph for detailed information on this use.^{230 1001}

Guideline-recommended options for PrEP include oral emtricitabine/tenofovir DF in sexually active adults and adolescents and men and women who inject drugs, oral emtricitabine/tenofovir alafenamide in men and transgender women who have sex with men, and IM cabotegravir in adults and adolescents.¹⁰⁰¹

Postexposure Prophylaxis following Occupational Exposure to HIV

Postexposure prophylaxis of HIV infection following occupational exposure^{† [off-label]} (PEP) in health-care personnel and others exposed via percutaneous injury (e.g., needlestick, cut with sharp object) or mucous membrane or nonintact skin (e.g., chapped, abraded, dermatitis) contact with blood, tissue, or other body fluids that might contain HIV.¹⁹⁹ Used in conjunction with other antiretrovirals.¹⁹⁹

USPHS recommends 3-drug regimen of raltegravir in conjunction with emtricitabine and tenofovir DF as the preferred regimen for PEP following occupational exposures to HIV.¹⁹⁹ Several alternative regimens that include an integrase strand transfer inhibitor (INSTI), nonnucleoside reverse transcriptase inhibitor (NNRTI), or protease inhibitor (PI) and 2 NRTIs (dual NRTIs) also recommended.¹⁹⁹ Preferred dual NRTI option for PEP regimens is emtricitabine and tenofovir DF (may be given as emtricitabine/tenofovir DF; Truvada); alternative dual NRTIs are tenofovir DF and lamivudine, lamivudine and zidovudine (may be given as lamivudine/zidovudine; Combivir), or zidovudine and emtricitabine.¹⁹⁹

Postexposure Prophylaxis following Nonoccupational Exposure to HIV

Postexposure prophylaxis of HIV infection following nonoccupational exposure^{† [off-label]} (nPEP) in individuals exposed to blood, genital secretions, or other potentially infectious body fluids that might contain HIV when the exposure represents a substantial risk for HIV transmission.¹⁹⁸ Used in conjunction with other antiretrovirals.¹⁹⁸

When nPEP indicated in adults and adolescents ≥13 years of age with normal renal function, CDC states preferred regimen is either raltegravir or dolutegravir used in conjunction with emtricitabine and tenofovir DF (given as emtricitabine/tenofovir DF; Truvada);¹⁹⁸ alternative recommended in these patients is ritonavir-boosted darunavir used in conjunction with emtricitabine/tenofovir DF (Truvada).¹⁹⁸

Chronic HBV Infection

Treatment of chronic HBV infection in adults and pediatric patients ≥2 years of age weighing ≥10 kg.¹

Tenofovir DF is a preferred initial treatment option when chronic HBV treatment is indicated; choice of antiviral medication should be individualized based on patient characteristics and comorbidities, treatment tolerability, and cost.⁹⁷

Tenofovir Disoproxil Fumarate Dosage and Administration

General

Pretreatment Screening

• Perform testing for HBV and HIV-1 infection prior to or when initiating tenofovir disoproxil fumarate (tenofovir DF).¹

• Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule prior to initiation of tenofovir DF.¹ In patients with chronic kidney disease, also assess serum phosphorus.¹

Patient Monitoring

• Assess serum creatinine, estimated creatinine clearance, urine glucose, and urine protein on a clinically appropriate schedule during treatment with tenofovir DF.¹ In patients with chronic kidney disease, also assess serum phosphorus.¹

• Monitor weight periodically during treatment with tenofovir DF and adjust dosage accordingly.¹

Dispensing and Administration Precautions

• Tenofovir DF is commercially available as a single entity and in various fixed-combination preparations that contain additional antiretrovirals.^{1 230 231 232 233 235 239 240} Refer to the full prescribing information for specific, distinct uses of the combination products.^{230 231 232 233 235 239 240} Since the antiretroviral agents contained in the fixed combination preparations also may be available in single-entity or other fixed-combination preparations, exercise care to ensure that therapy is not duplicated if a fixed combination is used in conjunction with other antiretrovirals.^{230 231 232 233 235 239 240}

Administration

Oral Administration

Available as oral tablets or oral powder.¹

Administer oral tablet once daily without regard to meals.¹

Administer oral powder once daily.¹ Measure dose using only the scoop provided by the manufacturer.¹ One level scoop delivers 1 g of powder, which contains 40 mg of tenofovir DF.¹ Mix required number of scoops with 2–4 ounces of soft food that can be swallowed without chewing (e.g., applesauce, baby food, yogurt); immediately ingest entire mixture to avoid a bitter taste.¹ Do not administer powder in liquid since powder may float to the top, even after stirring.¹

Dosage

Available as tenofovir DF; dosage expressed in terms of tenofovir DF.¹

Pediatric Patients

Treatment of HIV Infection

Oral

In pediatric patients ≥2 years of age weighing ≥35 kg, the recommended dosage is 300 mg once daily.¹

In pediatric patients ≥2 years of age weighing ≥17 and <35 kg who are able to swallow intact tablets, the recommended dosage is 8 mg/kg (up to a maximum of 300 mg) once daily (see Table 1).¹ Monitor weight periodically and adjust dosage accordingly.¹

In pediatric patients ≥2 years of age weighing ≥10 kg who are unable to swallow tablets, the recommended dosage is 8 mg/kg (up to a maximum of 300 mg) once daily using the powder (see Table 2).¹ Monitor weight periodically and adjust dosage accordingly.¹

Preexposure Prophylaxis for Prevention of HIV Infection

Oral

Usual dosage of tenofovir DF for preexposure prophylaxis (PrEP) for prevention of HIV infection (PreP) in adolescents weighing ≥35 kg is 300 mg once daily in conjunction with other antiretrovirals.²³⁰ The fixed-dose combination containing emtricitabine/tenofovir DF (Truvada) is used for PrEP; see the full prescribing information for specific dosage.²³⁰

Chronic HBV Infection

Oral

In pediatric patients ≥2 years of age weighing ≥35 kg, the recommended dosage is 300 mg once daily.¹ In those ≥2 years of age weighing ≥17 kg but <35 kg who are able to swallow intact tablets, the recommended dosage is 8 mg/kg (up to a maximum of 300 mg) once daily; dosage based on weight (Table 1).¹ Monitor weight periodically and adjust dosage accordingly.¹

In pediatric patients ≥2 years of age weighing ≥10 kg who are unable to swallow tablets, the recommended dosage of oral powder is 8 mg/kg (up to a maximum of 300 mg) once daily; dosage based on weight (Table 2).¹ Monitor weight periodically and adjust dosage accordingly.¹

Optimal duration of treatment unknown.¹

Adults

Treatment of HIV Infection

Oral

300 mg once daily in patients weighing ≥35 kg.¹ Dosage in adults weighing <35 kg is based on weight (see Table 1).¹ Monitor weight periodically and adjust dosage accordingly.¹

In patients unable to swallow tablets, recommended dosage of oral powder is 8 mg/kg (up to a maximum of 300 mg) once daily with food (see Table 2).¹

Preexposure Prophylaxis for HIV-1 Infection

Oral

Usual dosage of tenofovir DF for PreP is 300 mg once daily in conjunction with other antiretrovirals.²³⁰ The fixed-dose combination containing emtricitabine/tenofovir DF (Truvada) is used for PrEP; see the full prescribing information for specific dosage.²³⁰

Postexposure Prophylaxis following Occupational Exposure to HIV† [off-label]

Oral

Usual dosage of tenofovir DF for PEP is 300 mg once daily in conjunction with other antiretrovirals.¹⁹⁹ The preferred dual NRTI backbone option for use in PEP regimens is emtricitabine and tenofovir DF, commonly administered as the fixed-dose combination of emtricitabine/tenofovir DF (Truvada).¹⁹⁹ See the full prescribing information for specific dosage of emtricitabine/tenofovir DF (Truvada).²³⁰

Postexposure Prophylaxis following Nonoccupational Exposure to HIV† [off-label]

Oral

Usual dosage of tenofovir DF for nPEP is 300 mg once daily in conjunction with other antiretrovirals.¹⁹⁸ The preferred dual NRTI backbone option for use in nPEP regimens is emtricitabine and tenofovir DF, commonly administered as the fixed-dose combination of emtricitabine/tenofovir DF (Truvada).¹⁹⁸ See the full prescribing information for specific dosage of emtricitabine/tenofovir DF (Truvada).²³⁰

Chronic HBV Infection

Oral

300 mg once daily in patients weighing ≥35 kg.¹ Dosage in patients weighing <35 kg is based on weight (see Table 1).¹

In patients unable to swallow tablets, recommended dosage of oral powder is 8 mg/kg (up to a maximum of 300 mg) once daily with food (see Table 2).¹

Special Populations

Hepatic Impairment

No specific dosage recommendations.¹

Renal Impairment

Reduce dosage in adults with Cl_cr <50 mL/minute (see Table 3).¹ Dosage adjustments not needed in those with Cl_cr 50–80 mL/minute; however, monitor S_cr, estimated Cl_cr, serum phosphorus, urine glucose, and urine protein.¹ Dosage recommendations not available for patients with Cl_cr <10 mL/minute who are not undergoing hemodialysis, or for pediatric patients with renal impairment.¹

Geriatric Patients

No specific dosage recommendations.¹ Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Cautions for Tenofovir Disoproxil Fumarate

Contraindications

• None.¹

Warnings/Precautions

Warnings

Severe Acute Exacerbation of HBV Infection

Test all patients for presence of chronic HBV before or when initiating tenofovir disoproxil fumarate (tenofovir DF).¹ Severe acute exacerbations of HBV infection may occur following discontinuance of HBV treatment, including tenofovir DF.¹ Closely monitor hepatic function with both clinical and laboratory follow-up for at least several months after tenofovir DF is discontinued.¹ If appropriate, resumption of HBV treatment may be warranted, especially in patients with cirrhosis or advanced liver disease, since posttreatment exacerbation of HBV infection may lead to hepatic decompensation and liver failure.¹ (See Boxed Warning).

Other Warnings/Precautions

New Onset or Worsening Renal Impairment

Renal impairment, including acute renal failure and Fanconi syndrome (renal tubular injury with hypophosphatemia) reported with tenofovir DF.¹

Assess S_cr, estimated Cl_cr, urine glucose, and urine protein on a clinically appropriate schedule in all patients prior to or when initiating tenofovir DF, and during treatment with the drug.¹ In patients with CKD, also assess serum phosphorus.¹

In patients with Cl_cr <50 mL/minute, adjust dosing interval of tenofovir DF and closely monitor renal function.¹ Since no safety or efficacy data are available in patients with renal impairment who received tenofovir DF using dosing guidelines outlined in prescribing information, assess potential benefit of tenofovir DF therapy against potential risk of renal toxicity.¹

Avoid tenofovir DF in patients who are receiving or recently received nephrotoxic drugs (e.g., high-dose or multiple NSAIAs).¹

In patients at risk for renal dysfunction, promptly evaluate renal function if manifestations of proximal renal tubulopathy are present (i.e., persistent or worsening bone pain, pain in extremities, fractures, and/or muscular pain or weakness).¹

Individuals with HBV and HIV Type 1 Coinfection

Test all HIV-infected patients for presence of HBV before initiating tenofovir DF.¹

Offer HIV-1 testing for all HBV-infected patients before initiating tenofovir DF.¹

Due to the risk of development of HIV-1 resistance, only use tenofovir DF in patients with HBV and HIV-1 coinfection as part of an appropriate antiretroviral combination regimen.¹

Lactic Acidosis and Severe Hepatomegaly with Steatosis

Lactic acidosis and severe hepatomegaly with steatosis (sometimes fatal) reported in patients receiving nucleoside analogs, including tenofovir DF, alone or in conjunction with other antiretrovirals.¹

Suspend tenofovir DF therapy if there are clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (e.g., hepatomegaly and steatosis even in the absence of marked increases in serum aminotransferase concentrations).¹

Bone Loss and Mineralization Defects

In patients with HIV-1, tenofovir associated with slightly greater decreases in bone mineral density (BMD) and increases in biochemical markers of bone metabolism, suggesting increased bone turnover compared with other antiretroviral agents.¹

Increased serum parathyroid hormone and 1,25 vitamin D levels reported in HIV-infected adults receiving tenofovir DF.¹ Similar effects observed in pediatric patients with HIV-1 or HBV infection; however, skeletal growth appeared to be unaffected.¹

Clinical importance of these changes in BMD and biochemical markers on long-term bone health and fracture risk in adults and pediatric patients unknown.¹

Consider BMD monitoring in adult and pediatric patients with history of pathologic bone fracture or other risk factors for osteoporosis or bone loss.¹ Effect of calcium and vitamin D supplementation not studied, but may be beneficial.¹ If bone abnormalities suspected, obtain appropriate consultation.¹

Osteomalacia associated with proximal renal tubulopathy, which may contribute to fractures, reported; arthralgias and muscle pain or weakness also reported in patients with proximal renal tubulopathy.¹ Consider hypophosphatemia and osteomalacia secondary to proximal renal tubulopathy in patients at risk of renal dysfunction who present with persistent or worsening bone or muscle symptoms.¹

Immune Reconstitution Syndrome

Immune reconstitution syndrome reported in patients with HIV-1 treated with combination antiretroviral therapy, including tenofovir DF.¹ During initial treatment, HIV-infected patients who respond to antiretroviral therapy may develop an inflammatory response to indolent or residual opportunistic infections (e.g., Mycobacterium avium complex [MAC], M. tuberculosis, cytomegalovirus [CMV], Pneumocystis jirovecii [formerly P. carinii]); this may necessitate further evaluation and treatment.¹

Autoimmune disorders (e.g., Graves' disease, polymyositis, Guillain-Barré syndrome) also reported in the setting of immune reconstitution; time to onset is more variable and can occur many months after initiation of antiretroviral therapy.¹

Risk of Adverse Reactions Due to Drug Interactions

Concomitant use of tenofovir and certain drugs may result in known or potentially significant drug interactions, some of which may lead to possible clinically important adverse reactions from greater exposures of concomitant drugs.¹ Consult prescribing information for steps to prevent or manage possible and known significant drug interactions.¹

Consider potential for drug interactions before and during therapy with tenofovir; review concomitant medications during therapy; monitor for adverse reactions associated with concomitant drugs.¹

Specific Populations

Pregnancy

The Antiretroviral Pregnancy Registry (APR) monitors pregnancy outcomes in women exposed to tenofovir DF during pregnancy.¹ Clinicians are encouraged to register patients in the APR by calling 1-800-258-4263 or visiting [Web].¹

Based on data from APR, prevalence of birth defects in live births was 2.3% and 2.1% following first and second/third trimester exposure, respectively, to tenofovir DF-containing regimens.¹ Overall risk of birth defects with first-trimester exposure not markedly different compared to background rate for major birth defects in US reference population.¹

Tenofovir crosses human placenta.³² In published studies that included HBV-infected pregnant women treated with tenofovir DF, increased risk of adverse pregnancy-related outcomes not observed with use of the drug during third trimester.¹

No adverse developmental effects observed in animal reproductive studies.¹

Lactation

Tenofovir distributed into human milk in low concentrations.^{1 34} In a study of breast-feeding women (not infected with HIV) who were on a tenofovir-containing regimen started between 1–24 weeks postpartum, tenofovir was undetectable in the plasma of most infants after 7 days of treatment in mothers.¹ No serious adverse events reported in mothers or infants.¹

Not known whether tenofovir DF affects human milk production or has effects on the breast-fed infant.¹

If using tenofovir DF for treatment of HIV-1 infection, instruct HIV-infected women not to breast-feed because of potential for the following: HIV transmission in HIV-negative infants, development of viral resistance in HIV-positive infants, and adverse reactions in the breast-fed infant similar to those observed in adults.¹

If using tenofovir DF for treatment of HBV infection, consider developmental and health benefits of breast-feeding and the importance of tenofovir DF to the mother along with the potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.¹

Pediatric Use

Safety and efficacy for treatment of HIV-1 infection established in pediatric patients 2 to <18 years of age.¹ Safety and efficacy not established in children <2 years of age weighing <10 kg.¹

Safety and efficacy established for treatment of chronic HBV infection in pediatric patients 2 to <18 years of age.¹ Safety and efficacy not established in children <2 years of age weighing <10 kg.¹

Geriatric Use

Clinical studies did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently to tenofovir DF than younger adults.¹ Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹

Hepatic Impairment

Pharmacokinetics not substantially altered in patients with moderate or severe hepatic impairment.¹

Renal Impairment

Principally eliminated by kidneys.¹

Adjust dosage interval in moderate or severe renal impairment (Cl_cr<50 mL/minute or end-stage renal disease requiring dialysis).¹

Common Adverse Effects

Most common adverse effects (incidence ≥10%; grades 2–4) in HIV-infected patients include rash, diarrhea, headache, pain, depression, asthenia, nausea.¹

Most common adverse effect (all grades) in HBV-infected patients with compensated liver disease was nausea (9%).¹

Most common adverse effects (incidence ≥10%; all grades) in HBV-infected patients with decompensated liver disease include abdominal pain, nausea, vomiting, pruritus, insomnia, dizziness, pyrexia.¹

Adverse reactions in pediatric patients were consistent with those observed in adults.¹

Drug Interactions

Tenofovir DF and tenofovir are not substrates of CYP enzymes; tenofovir does not inhibit CYP3A4, 2D6, 2C9, or 2E1, but may have a slight inhibitory effect on CYP1A.¹

Substrate of P-glycoprotein (P-gp) transport system.¹

Substrate of breast cancer resistance protein (BCRP).¹

The following drug interactions are based on studies using tenofovir DF; refer to the full prescribing information for further details.¹ Additional drug interactions may exist for fixed-combinations containing emtricitabine and tenofovir DF (Truvada); doravirine, lamivudine, and tenofovir DF (Delstrigo); efavirenz, emtricitabine, and tenofovir DF (Atripla); emtricitabine, rilpivirine, and tenofovir DF (Complera); elvitegravir, cobicistat, emtricitabine, and tenofovir DF (Stribild); and efavirenz, lamivudine and tenofovir (Symfi and Symfi Lo).^{230 231 232 233 235 239 240}

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

CYP inhibitors or substrates: Pharmacokinetic interactions unlikely.¹

Drugs Affecting P-glycoprotein Transport System

P-gp inhibitors: Concomitant use may increase absorption of tenofovir DF, resulting in increased plasma concentrations of the drug.¹

Drugs Affecting Breast Cancer Resistance Protein

BCRP inhibitors: Concomitant use may increase absorption of tenofovir DF, resulting in increased plasma concentrations of the drug.¹

Nephrotoxic Drugs or Drugs Eliminated by Renal Excretion

Drugs that reduce renal function or compete for active tubular secretion: Potential increased concentrations of tenofovir and/or concomitant drug.¹

Specific Drugs

Tenofovir Disoproxil Fumarate Pharmacokinetics

Absorption

Bioavailability

Pharmacokinetics in healthy individuals similar to those in individuals with HIV-1 infection.¹

Tenofovir DF is a diester prodrug of tenofovir.¹

Oral bioavailability of tenofovir from tenofovir DF is approximately 25%; peak plasma concentrations attained in about 1 hour in fasting HIV-infected patients.¹

In nonfasting individuals, mean peak plasma concentrations were 26% lower when administered as an oral powder compared with administration as tablets; mean AUC was similar with both preparations.¹

Food

Food delays time to peak plasma tenofovir concentrations by approximately 1 hour.¹ Administration with a high-fat meal increases oral bioavailability of tenofovir (14% increase in peak plasma concentrations; 40% increase in AUC); pharmacokinetics not appreciably affected by administration with a light meal.¹

Distribution

Extent

Tenofovir distributed into semen³⁵ and vaginal tissue and cervicovaginal fluid in low concentrations following oral administration.^{30 31 32 36} Very low concentrations may be distributed into saliva.³³

Plasma Protein Binding

In vitro binding to plasma or serum proteins is <0.7 or 7.2%, respectively, over tenofovir concentrations of 0.01–25 mcg/mL.¹

Elimination

Metabolism

Tenofovir DF requires initial diester hydrolysis for conversion to tenofovir and subsequent phosphorylation by cellular enzymes to form the active tenofovir diphosphate.¹

Tenofovir and its prodrug are not substrates of CYP enzymes.¹

Elimination Route

Tenofovir eliminated principally by kidneys using glomerular filtration and active tubular secretion; approximately 32% of an oral dose eliminated in urine within 24 hours.¹

Tenofovir removed by hemodialysis.¹

Half-life

Approximately 17 hours.¹

Special Populations

No substantial changes in tenofovir pharmacokinetics in individuals with moderate to severe hepatic impairment compared with those with normal hepatic function.¹

Moderate to severe renal impairment (Cl_cr <50 mL/minute or end-stage renal disease requiring dialysis) results in increased plasma concentrations and AUC.¹

Stability

Storage

Oral

Powder

25°C (excursions permitted between 15–30°C).¹ Dispense in original container; keep container tightly closed.¹

Tablets

25°C (excursions permitted between 15–30°C).¹ Dispense in original container; keep container tightly closed.¹

Actions and Spectrum

• Tenofovir DF is an HIV NRTI.^{1 2 3} Prodrug that is inactive until hydrolyzed in vivo to tenofovir which is then phosphorylated to the active metabolite (tenofovir diphosphate).^{1 2 3}

• Active in vitro and in vivo against HIV-1 and HBV; some activity against HIV-2.¹

• Inhibits replication of retroviruses, including HIV-1, by interfering with viral RNA-directed DNA polymerase (reverse transcriptase).^{1 2 3}

• Inhibits HBV replication through competitive inhibition of viral reverse transcriptase.¹

• Weak inhibitor of mammalian DNA α- and β-polymerases and mitochondrial DNA γ-polymerase.^{1 4} Low potential to induce mitochondrial toxicity.⁴

• HIV-1 resistant to tenofovir can be selected in vitro and has been reported in clinical isolates.¹ HIV-1 strains with reduced susceptibility to tenofovir have K65R and K70E substitutions in reverse transcriptase.¹

• HIV resistant to tenofovir may be cross-resistant to some NRTIs.¹ Cross-resistance with HIV PIs or NNRTIs unlikely.

• May be active against HBV resistant to adefovir and/or lamivudine.^{1 26 29} Some adefovir-, entecavir-, lamivudine-, or telbivudine-resistant HBV may have reduced susceptibility to tenofovir.¹

Advice to Patients

• Inform patients that it is important to use tenofovir DF in conjunction with other antiretrovirals for treatment of HIV-1 infection, and not as monotherapy.¹

• Inform patients that severe acute exacerbations of hepatitis B have occurred in patients infected with HBV who have discontinued tenofovir DF.¹ Advise patients not to discontinue tenofovir DF without first informing their clinician.¹ Inform patients that testing for HBV infection is required before or when starting tenofovir DF, and that those who are infected with HBV require close medical follow-up for several months after discontinuing tenofovir DF to monitor for exacerbations of hepatitis.¹

• Inform patients that renal impairment, including cases of acute renal failure and Fanconi syndrome, have occurred in patients using tenofovir DF.¹ Advise patients to avoid tenofovir DF with concurrent or recent use of a nephrotoxic agent.¹ Inform patients that the dosage of tenofovir DF may need to be adjusted in renal impairment.¹

• Inform patients that, in some patients with acquired immunodeficiency syndrome (AIDS), signs and symptoms of inflammation from previous infections may occur soon after starting a medication for HIV.¹ Inform patients that these symptoms are likely due to an improvement in the body's immune response, allowing the body to fight infections that may have been present without obvious symptoms.¹ Advise patients to inform their clinician immediately if any symptoms of infection occur.¹

• Inform patients that decreases in BMD have been observed in patients using tenofovir DF.¹ Advise patients with a history of pathologic bone fracture or at risk for osteopenia to consider bone monitoring.¹

• Inform patients that lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported in patients taking tenofovir DF.¹ Inform patients that their clinician may discontinue treatment with tenofovir if clinical symptoms suggestive of lactic acidosis or pronounced hepatotoxicity develop.¹

• Advise patients that it is critical to be compliant with HIV therapy and to remain under the care of a clinician.¹ Inform patients to take tenofovir DF on a regular dosing schedule and to avoid missing doses in order to prevent the development of resistance.¹ Inform patients to not alter or discontinue the antiretroviral regimen without consulting their clinician.¹

• Advise patients that the optimal duration of therapy for the treatment of chronic hepatitis B is unknown.¹ Inform patients that the relationship between response to treatment and long-term prevention of outcomes such as hepatocellular carcinoma is unknown.¹

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.¹ Inform patients that there is a pregnancy registry to monitor fetal outcomes of pregnant women exposed to tenofovir DF.¹ Advise HIV-infected women not to breast-feed while taking tenofovir DF.¹

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal products, as well as concomitant illnesses.¹ Inform patients that tenofovir DF may interact with many drugs, including other HIV drugs and drugs for treatment of hepatitis C virus.¹

• Advise patients of other important precautionary information.¹

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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